BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERRUCA FREEZE

    MDR report key: 516089 · Received March 3, 2004

    Report

    Report Number
    MW1031416
    Event Type
    Injury
    Date Received
    March 3, 2004
    Date of Event
    October 16, 2003
    Report Date
    March 3, 2004
    Manufacturer
    CRYOSURGERY, INC.
    Product Code
    GEH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 5/28/04: IT TOOK MANY MONTHS BEFORE MFR OBTAINED ALL THE INFO FROM BOTH SIDES AND JUST DISCOVERED MORE INFO THE DAY MFR RECEIVED LETTER. A PHYSICIAN ASSISTANT INVESTIGATOR FROM THE STATE PROFESSIONAL RESPONSIBILITY BOARD CALLED AND DISCUSSED THE SITUATION. HE CONFIRMED THAT THE PHYSICIAN ASSISTANT USED KY JELLY AROUND THE EDGE OF THE CONE AND TOLD MFR IT WAS BECAUSE THE PA COULD NOT GET A COMPLETE SEAL ON THE TOE WITH THE CONE THEY WERE USING. IN CASES LIKE THIS MFR'S INSTRUCTION CRYOBUD FOAM SWAB SHOULD BE USED. KY JELLY IS NOT RECOMMENDED TO BE USED WITH VERRUCA-FREEZE.

    Description of Event or Problem · 1

    THE PRODUCT WAS BEING UTILIZED IN THE REMOVAL OF THE WART FROM RIGHT 5TH TOE. THE PHYSICIAN ASSISTANT PERFORMED THE PROCEDURES. SOMEHOW, DURING THE PROCEDURE, PT SUSTAINED SERIOUS COLD BURNS TO 4TH AND 5TH RIGHT TOES AND THE DORSAL ASPECT OF RIGHT FOOT. THE CAN WAS SENT BACK TO CRYOSURGERY IN 10/03. PER A RESPONSE WRITTEN BY MEDICAL BOARD REGARDING THIS INCIDENT, THE CAN WAS FOUND TO BE DEFECTIVE WITH A "1 IN 100,000" DEFECT THAT IN COMBINATION WITH USER ERROR RESULTED IN THE BURNS. ALSO IN DR'S LETTER, HE STATES THAT AT THE REQUEST OF CRYOSURGERY, INC. HE WOULD NOT DISCUSS THE RESULTS OF THE CAN MALFUNCTION WITH REPORTER. PT REQUIRED ANTIBIOTICS, NARCOTIC PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERRUCA FREEZE WART REMOVAL PRODUCT GEH CRYOSURGERY, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention